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Oral squamous cell carcinoma is the most common malignant tumor of the oral and maxillofacial region. Currently, surgery is the main method of comprehensive treatment. TPF (paclitaxel, cisplatin, and fluorouracil) chemotherapy regimen is one of the important methods for the treatment of oral squamous cell carcinoma. Adjuvant chemotherapy before and after surgery can significantly improve the therapeutic effect of oral cancer patients. Oral mucositis (OM) is a common side effect during chemotherapy, which seriously affects the quality of life of chemotherapy patients and may lead to the termination of chemotherapy. Prevention and treatment of oral mucositis is still an urgent clinical problem. Investigators' previous studies have found that vitamin D can significantly inhibit the proliferation, migration, invasion and metastasis of oral squamous cell carcinoma cells, and vitamin D can protect normal oral mucosal tissue by inhibiting pyroptosis caused by platinum-based chemotherapy drugs. Based on the previous basic research, this project intends to conduct a single-center, prospective, clinical randomized controlled study on the clinical efficacy of vitamin D in reducing oral mucosal inflammation in patients with oral squamous cell carcinoma undergoing TPF chemotherapy, in order to provide evidence-based medical evidence for the clinical use of vitamin D in reducing oral mucosal inflammation in patients with oral cancer chemotherapy. The results of this study are expected to serve as guidelines to guide clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention group | Experimental | Alfacalcidol Drops,1ug a day,40day |
|
| control group | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alfacalcidol Oral Solution | Drug | Alfacalcidol Oral Solution 1ug a day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Within two months from the start of chemotherapy | Oral mucosal hyperemia, erythema, erosion, ulceration and fibrosis appear, accompanied by clinical manifestations such as pain, difficulty eating, dry mouth, and taste disturbance. | Within two months from the start of chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Grading of oral mucositis in patients treated with vitamin D and placebo | According to the American Oncology Nurse Oral Mucositis Evaluation Scale, the score <8 is normal; 9-10 is mild; 11-12 is moderate; >12 is severe | Within two months from the start of chemotherapy |
| Changes in the quality of life of patients in vitamin D treatment group and placebo group before |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen Memorial Hospital | Recruiting | Guangzhou | Guangdong | China |
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| Placebo |
| Drug |
Placebo |
|
University of Washington quality of life scale |
| Within two months from the start of chemotherapy |
| Healing time of oral mucositis in vitamin D treatment group and placebo group | Time to cure of patients with oral mucositis | Within two months from the end of chemotherapy |
| Length of hospital stay of patients in vitamin D treatment group and placebo group | Length of hospital stay | Within two months from the start of chemotherapy |
| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D013280 | Stomatitis |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| C008088 | alfacalcidol |
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